Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution. The full amount of solution should be inserted slowly into the space between the gum and the cheek. No data are available.īUCCOLAM is for oromucosal use. The safety and efficacy of midazolam in children aged 0 to 3 months has not been established. Therefore, the clinical effects may be stronger and prolonged, hence careful monitoring of the clinical effects and vital signs is recommended following administration of midazolam in patients with hepatic impairment (see section 4.4).īUCCOLAM is contraindicated in patients with severe hepatic impairment (see section 4.3). Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal half-life. No dose adjustment is required, however, BUCCOLAM should be used with caution in patients with chronic renal failure as elimination of midazolam may be delayed and the effects prolonged. If the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought and the empty syringe given to the healthcare professional to provide information on the dose received by the patient.Ī second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice (see section 5.2).
Carers should only administer a single dose of midazolam.
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